Evidence map›Paper›PMID 32401633›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Phase I/II Study of CPX-351 Followed by Fludarabine, Cytarabine, and Granulocyte-Colony Stimulating Factor for Children With Relapsed Acute Myeloid Leukemia: A Report From the Children's Oncology Group.

Todd M Cooper, Michael J Absalon, Todd A Alonzo, Robert B Gerbing, Kasey J Leger, Betsy A Hirsch, Jessica Pollard, Bassem I Razzouk, Richard Aplenc, E Anders Kolb

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06928909 (Evaluating the Feasibility of an Intensity-Adapted Pediatric Acute Myeloid Leukemia Treatment Guideline in Malawi), which is not on this map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
4.8field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06928909 recruitingnot on this mapstarted 2025, after this paper: background citation

Evaluating the Feasibility of an Intensity-Adapted Pediatric Acute Myeloid Leukemia Treatment Guideline in Malawi

TypeobservationalSponsorBaylor College of MedicineRan2025 to 2030Enrolled30ConditionsAcute Myeloid LeukaemiaArmsIntensity-adapted pediatric acute myeloid treatment guidelines
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 61 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 9 institutions in 1 country.

Todd M CooperDepartment of Hematology/Oncology, Cancer and Blood Disorders Center, Seattle Children's Hospital, Seattle, WA.
Michael J AbsalonCincinnati Children's Hospital Medical Center, Cincinnati, OH.
Todd A AlonzoDepartment of Preventive Medicine, University of Southern California, Los Angeles, CA.
Robert B GerbingChildren's Oncology Group, Monrovia, CA.
Kasey J LegerDepartment of Hematology/Oncology, Cancer and Blood Disorders Center, Seattle Children's Hospital, Seattle, WA.
Betsy A HirschUniversity of Minnesota, Minneapolis, MN.
Jessica PollardDana-Farber Cancer Institute/Boston Children's Hospital, Boston, MA.
Bassem I RazzoukPeyton Manning Children's Hospital at St Vincent, Indianapolis, IN.
Richard AplencChildren's Hospital of Philadelphia, Philadelphia, PA.
E Anders KolbNemours Center for Cancer and Blood Disorders/Alfred I. DuPont Hospital for Children, Wilmington, DE.
Seattle Children's Hospital · USBoston Children's Hospital · USChildren's Hospital of Philadelphia · USChildren's Oncology Group · USCincinnati Children's Hospital Medical Center · USDuPont (United States) · USPeyton Manning Children’s Hospital at St.Vincent · USUniversity of Minnesota · USUniversity of Southern California · US

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899
6 · The paper itself

Abstract

purposeEffective regimens are needed for children with relapsed acute myeloid leukemia (AML). AAML1421 is a phase I/II study of CPX-351, a liposomal preparation of daunorubicin and cytarabine. AAML1421 sought to determine the recommended phase II dose (RP2D) of CPX-351 and the response rate after up to 2 cycles of therapy. PATIENTS AND

methodsChildren > 1 and ≤ 21 years of age with relapsed/refractory AML were eligible for dose finding; those in first relapse were eligible for the efficacy phase. Dose-limiting toxicity (DLT) assessment occurred during cycle 1. Two cycles of therapy were offered (cycle 1: CPX-351; cycle 2: FLAG [fludarabine 30 mg/m

resultsThirty-eight patients enrolled: 6 in the dose-finding phase and 32 in the efficacy phase. During dose finding, 1/6 patients experienced a DLT (grade 3 decrease in ejection fraction). The RP2D was 135 units/m

conclusionThe RP2D of CPX-351 is 135 units/m

Indexed as

AdolescentAdultChildChild, PreschoolCytarabineFemaleGranulocyte Colony-Stimulating FactorHumansInfantLeukemia, Myeloid, AcuteMaleRecurrenceVidarabineYoung AdultCytarabinefludarabineGranulocyte Colony-Stimulating FactorVidarabine

Identifiers

PMID32401633
PMCPMC7325367
OpenAlexW3025300208

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.